Optimizing Health Among Children With Congenital Heart Defects
Optimizing Health Among Children With Congenital Heart Defects Through Rehabilitation Focused on Physical Activity Determinants
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Therefore, we hypothesize that psychosocial factors are important determinants of PAP in this population. Our most recent research with children who have univentricular heart indicates that gross motor skill and psychosocial factors are significant correlates of PAP. Important psychosocial factors include self-efficacy for activity, uncertainty about activity, and inaccurate perceptions of the child's PAP level, options, and abilities. This study seeks to determine whether gross motor skill and psychosocial factors influence PAP among children with a broad spectrum of cardiac defects. It will also determine the optimal changes to clinical care needed to encourage children with heart defects to develop health-related active lifestyles.
We propose a prospective, randomized, cross-over preliminary clinical trial utilizing both quantitative and qualitative assessments. Through the cross-over design, each subject will complete both interventions (information, demonstration), with the order of intervention delivery randomly determined. Quantitative assessments will document moderate-to-vigorous physical activity (MVPA), gross motor skill, and health-related fitness. Qualitative assessments will evaluate parent/child anxiety about PAP and psychosocial factors influencing PAP. All factors will be assessed at each data collection point.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Ontario
-
Toronto, Ontario, Канада
- The Hospital for Sick Children
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Successful repair of one of the following congenital heart defects: transcatheter device closure of atrial septal defect (ASD), arterial switch repair of transposition of the great arteries (TGA), surgical repair of tetralogy of Fallot (TOF), or Fontan procedure for a functionally univentricular heart (UVH).
- At least one year after most recent open heart surgery.
- 4 to 11 years of age and attending elementary school at first study visit.
Exclusion Criteria:
- Identification of exercise contraindications/limitations by the responsible cardiologist.
- Other disabilities or medical conditions that may influence PAP. Children who achieve 90 minutes of MVPA on 5 or more days per week during the baseline assessment will be excluded from the intervention phase. The study interventions are not designed to increase MVPA among children who already achieve the Health Canada guidelines for PAP.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Группа 1
|
The information intervention is designed to ensure that the parent(s) and child have a clear understanding of the range of physical activity opportunities that are appropriate and recommended for the child.
The information intervention will be comprised of discussions and written information.
The demonstration intervention will be designed to demonstrate to the child and parent(s) specifically what the child is able to do in relation to fitness and motor skill activities.
The demonstration intervention will consist of having the child complete a standardized exercise testing protocol on the treadmill, followed by discussions with the child and parent(s) to convey the results of the study testing of fitness and gross motor skill.
|
|
Активный компаратор: Группа 2
|
The information intervention is designed to ensure that the parent(s) and child have a clear understanding of the range of physical activity opportunities that are appropriate and recommended for the child.
The information intervention will be comprised of discussions and written information.
The demonstration intervention will be designed to demonstrate to the child and parent(s) specifically what the child is able to do in relation to fitness and motor skill activities.
The demonstration intervention will consist of having the child complete a standardized exercise testing protocol on the treadmill, followed by discussions with the child and parent(s) to convey the results of the study testing of fitness and gross motor skill.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Difference in change of measured moderate-to-vigorous physical activity (MVPA) between groups
Временное ограничение: Baseline, 4, 8 and 12 month timepoints
|
Baseline, 4, 8 and 12 month timepoints
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Gross motor skill
Временное ограничение: Baseline, 4, 8 and 12 month timepoints
|
Baseline, 4, 8 and 12 month timepoints
|
|
Psychosocial variables
Временное ограничение: Baseline, 4, 8 and 12 month timepoints
|
Baseline, 4, 8 and 12 month timepoints
|
|
Health-related fitness
Временное ограничение: Baseline, 4, 8 and 12 month timepoints
|
Baseline, 4, 8 and 12 month timepoints
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Brain W McCrindle, MD, The Hospital for Sick Children
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 1000012482
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .